Safety and compliance among newly qualified paramedics in a pre-hospital clinical trial of an investigational medicinal product: a post-hoc analysis of the PACKMaN randomised controlled trial
In a double-blind controlled trial of an investigational medicinal product, there was no statistical difference in the incidence of AEs or NCs between NQPs and experienced paramedics. NQPs made an important contribution to patient recruitment in this study, improving the generalisability. SAEs and NCs were rare, and patients received analgesics safely. There was no correlation between experience and AE likelihood, and no safety concerns identified arising from NQP participation. Our findings demonstrate that NQPs can safely recruit patients to clinical trials.
Authors
- Zoe Green
- Hannah Noordali
- Felix Michelet (ORCID: https://orcid.org/0009-0003-6903-7637)
- Michael A. Smyth (ORCID: https://orcid.org/0000-0003-0220-2223)
- Owen Stanley (ORCID: https://orcid.org/0009-0007-9924-4281)
- Ranjit Lall (ORCID: https://orcid.org/0000-0003-1737-2866)
- Josh Miller (ORCID: https://orcid.org/0000-0003-1990-4029)
- Elisha Miller (ORCID: https://orcid.org/0000-0003-4729-8572)
- Imogen Gunson (ORCID: https://orcid.org/0000-0001-8335-3335)
- Andy Rosser (ORCID: https://orcid.org/0000-0002-5477-4269)
- Gavin D. Perkins (ORCID: https://orcid.org/0000-0003-3027-7548)
Institutions
- University of Warwick (GB)
- South Western Ambulance Service NHS Foundation Trust (GB)
- Yorkshire Ambulance Service NHS Trust (GB)
- ORCID (US)
- East Midlands Ambulance Service NHS Trust (GB)
Publication Details
- Journal
- British Paramedic Journal
- Published
- 2025-11-27
- DOI
- https://doi.org/10.29045/14784726.2025.12.10.3.10
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 0.00